Covid-19PRESAGENCT04528901
Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
An observational study of Covid-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
seroPREvalence vis-à-vis SARS-CoV2 and correlation with clinical forms of COVID-19 in patients followed in Pulmonology in the cluster area of the Grand-Est region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- How many people
- 1,080 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient followed in pulmonology at Strasbourg University Hospital
Who may be able to join
- Man or woman from 18 years old and without upper age limit
- Patient followed in pulmonology at Strasbourg University Hospital
- Patient presenting at least one of the following pathologies:
- severe persistent asthma (200 patients)
- chest cancer that is active or has received treatment within a period of less than one year (300 patients)
- history of lung transplantation performed before the start of the epidemic (02/29/2020) (300 patients)
Show all 12Show fewer
- idiopathic or other diffuse interstitial lung disease, sarcoidosis or vasculitis (70 patients)
- pulmonary arterial hypertension (PAH) (group 1 of the international classification) any cause or chronic thromboembolic PAH (group 4): (60 patients)
- Severe COPD in the respiratory failure stage (150 patients)
- Subject affiliated to a social health insurance protection scheme
- Subject able to understand the objectives of the research
- Subject having signed an informed consent
Who cannot join
- Inability to provide informed information about the subject (subject in an emergency situation, difficulty in understanding the subject, etc.)
- Subject under safeguard of justice
- Subject under guardianship or guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas-Rhin, 67091
Céline MASCAUX, +33 3 69 55 06 44, Celine.mascaux@chru-strabourg.fr
Céline MASCAUX
About this study
seroPREvalence vis-à-vis SARS-CoV2 and correlation with clinical forms of COVID-19 in patients followed in Pulmonology in the cluster area of the Grand-Est region.
- Conditions
- Covid-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine and compare the seroprevalence for SARS-CoV2 among patients with respiratory pathologies monitored in Pneumology at the Strasbourg University Hospital, in the cluster zone of the Grand Est.
Carrying out a serological assay of specific antibodies to SARS-CoV-2
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start4 Sep 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline MASCAUX, Principal investigator, CHU de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528901
- Sponsor's protocol ID
- 7879
- Acronym
- PRESAGE
- Status last verified
- Sep 2020
- First submitted
- 25 Aug 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
- ClinicalTrials.gov ID
- NCT04528901
- Acronym / sponsor ID
- PRESAGE / 7879
- Conditions
- Covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
seroPREvalence vis-à-vis SARS-CoV2 and correlation with clinical forms of COVID-19 in patients followed in Pulmonology in the cluster area of the Grand-Est region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient followed in pulmonology at Strasbourg University Hospital
Key inclusion criteria (12 listed)
- Man or woman from 18 years old and without upper age limit
- Patient followed in pulmonology at Strasbourg University Hospital
- Patient presenting at least one of the following pathologies:
- Subject affiliated to a social health insurance protection scheme
- Subject able to understand the objectives of the research
Key exclusion criteria (3 listed)
- Inability to provide informed information about the subject (subject in an emergency situation, difficulty in understanding the subject, etc.)
- Subject under safeguard of justice
- Subject under guardianship or guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine and compare the seroprevalence for SARS-CoV2 among patients with respiratory pathologies monitored in Pneumology at the Strasbourg University Hospital, in the cluster zone of the Grand Est.
Time frame: 15 months
Carrying out a serological assay of specific antibodies to SARS-CoV-2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline MASCAUX principal investigator
CHU de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Céline MASCAUX (+ 3 33 69 55 06 44, Celine.mascaux@chru-strabourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine and compare the seroprevalence for SARS-CoV2 among patients with respiratory pathologies monitored in Pneumology at the Strasbourg University Hospital, in the cluster zone of the Grand Est. (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.